title: Validation of two rapid diagnostic tests for visceral leishmaniasis in Kenya.
abstract: BACKGROUND
  Visceral leishmaniasis (VL) is a systemic parasitic disease that is fatal unless treated. In Kenya, national VL guidelines rely on microscopic examination of spleen aspirate to confirm diagnosis. As this procedure is invasive, it cannot be safely implemented in peripheral health structures, where non-invasive, accurate, easy to use diagnostic tests are needed.
  
  
  METHODS
  We evaluated the sensitivity, specificity and predictive values of two rapid diagnostic tests (RDT), DiaMed IT LEISH and Signal-KA, among consecutive patients with clinical suspicion of VL in two treatment centres located in Baringo and North Pokot District, Rift Valley province, Kenya. Microscopic examination of spleen aspirate was the reference diagnostic standard. Patients were prospectively recruited between May 2010 and July 2011.
  
  
  RESULTS
  Of 251 eligible patients, 219 patients were analyzed, including 131 VL and 88 non-VL patients. The median age of VL patients was 16 years with predominance of males (66%). None of the tested VL patients were co-infected with HIV. Sensitivity and specificity of the DiaMed IT LEISH were 89.3% (95%CI: 82.7-94%) and 89.8% (95%CI: 81.5-95.2%), respectively. The Signal KA showed trends towards lower sensitivity (77.1%; 95%CI: 68.9-84%) and higher specificity (95.5%; 95%CI: 88.7-98.7%). Combining the tests did not improve the overall diagnostic performance, as all patients with a positive Signal KA were also positive with the DiaMed IT LEISH.
  
  
  CONCLUSIONS
  The DiaMed IT LEISH can be used to diagnose VL in Kenyan peripheral health facilities where microscopic examination of spleen aspirate or sophisticated serological techniques are not feasible. There is a crucial need for an improved RDT for VL diagnosis in East Africa.
authors.affiliation: Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
authors.forename: Jane
authors.initials: J
authors.lastname: Mbui
authors.forename: Monique
authors.initials: M
authors.lastname: Wasunna
authors.forename: Manica
authors.initials: M
authors.lastname: Balasegaram
authors.forename: Adrian
authors.initials: A
authors.lastname: Laussermayer
authors.forename: Rashid
authors.initials: R
authors.lastname: Juma
authors.forename: Simon Njoroge
authors.initials: SN
authors.lastname: Njenga
authors.forename: George
authors.initials: G
authors.lastname: Kirigi
authors.forename: Mark
authors.initials: M
authors.lastname: Riongoita
authors.forename: Roberto
authors.initials: R
authors.lastname: de la Tour
authors.forename: Joke
authors.initials: J
authors.lastname: van Peteghem
authors.forename: Raymond
authors.initials: R
authors.lastname: Omollo
authors.forename: François
authors.initials: F
authors.lastname: Chappuis
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D006801:Humans; D007630:Kenya; D007898:Leishmaniasis, Visceral / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D055815:Young Adult